Once a laboratory synthesis has been established, we conduct all development work relating to the scaling-up as well as the transfer to production operation (incl. process validation as per ICH Q7).

Our process development services

• Transfer of laboratory syntheses (own or external processes) to pilot plant and production scale (scaling up to approximately
  30 kg of final product in own facility, larger batches with partner company)
• Manufacture and characterization of by-products (impurities and degradation products) of the drug synthesis
• Validation of manufacturing processes in accordance with
  ICH Q7
• Optimization of existing manufacturing processes
• Purification of substances and separation of mixtures of materials, e.g. rectification, fractional distillation, crystallization and extraction on the laboratory scale